Draeger, a subsidiary of Draegerwerk AG & Co. KGaA, is initiating a voluntary recall notification for Draeger Coax Ventilation Hoses, Draeger Neo Disposable Breathing Systems, Draeger Pediatric Disposable Breathing Systems, Draeger Seattle PAP plus, and Draeger Set2Go to address the potential risk that glued connections of the breathing circuits may loosen either before or during the ventilation process.
The loosened equipment could result in partial or complete detachment of components such as the water trap, y-piece, or hose connector. To date, there are no reports of any adverse impacts on the health of patients in connection with this potential risk.
Draeger immediately stopped shipment of affected products once these potential risks were identified, according to the company. Draeger has since implemented changes to the gluing process used during manufacturing to help address these potential risks.
Testing of the updated gluing process has been completed for Seattle PAP (MP02260), and Draeger started distributing Seattle PAP product utilizing this updated gluing process to customers as of March 20, 2023. Testing is still ongoing for the remaining circuits, and all impacted customers have been offered an alternative product as a temporary replacement.
If customers received breathing circuits that were shipped prior to March 20 that may be affected by this issue, the company suggests:
- Stop use of the affected products. Inspect current stock and quarantine/segregate any unused affected products to prevent their use.
- Alternative therapy should be instituted as soon as possible. These alternative therapies may include: nasal continuous positive airway pressure (nCPAP), noninvasive positive pressure ventilation (NIPPV), high flow nasal canula, and invasive mechanical ventilation (last resort).
- Do not depend on any device output (e.g., oxygen desaturation) to make decisions regarding whether to stop using the system.
- Please ensure that all users of the above-mentioned products and other persons within your organization are made aware of this Urgent Medical Device Recall.
- Please keep this information available to all users at least until you have checked your stock and quarantined/segregated any unused affected products to prevent their use.